Salvage mFOLFOX in BTC After Failure of Gemcitabine

NCT01127555 | Completed Phase 2

• 1 other identifier: CAUHHO 2010-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of mFOLFOX (5-fluorouracil, leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer who had failed gemcitabine.

Conditions

Unresectable Biliary Tract Cancer

Keywords

Biliary Tract Cancer; Salvage therapy; FOLFOX

Outcome Measures

Primary Outcomes (1)

• Response rate

  Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan

  1 year

Secondary Outcomes (3)

• To evaluate the safety

  1 year

• To estimate the time to progression

  1 year

• To estimate overall survival

  1 year

Interventions

5-fluorouracil, leucovorin, oxaliplatin DRUG

D1 Oxaliplatin 85mg/m2 D1, 2 LV 30mg/m2 IV push D1, 2 5-FU 1500mg/m2 CIV over 24hrs Every 2 weeks

Also known as: mFOLFOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age : older than 18
• Histologically confirmed adenocarcinoma of the biliary tract
• Metastatic or unresectable biliary cancer
• Prior exposure to gemcitabine chemotherapy for biliary cancer
• Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
• A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral Computed Tomography (CT) or multidetector CT
• Adequate bone marrow, liver, renal function

You may not qualify if:

• Pregnancy and breast-feeding.
• Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
• Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
• Symptomatic or uncontrolled brain metastasis

Sponsors & Collaborators

• Chung-Ang University: lead
• Gyeongsang National University Hospital: collaborator
• Dong-A University Hospital: collaborator
• Samsung Medical Center: collaborator

Study Sites (1)

Chung-Ang University Yongsan Hospital

Yongsan, Seoul, 140-757, South Korea

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• In Gyu Hwang, M.D.

  Chung-Ang University Yongsan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chung-Ang University Hospital

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 21, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: January 1, 2013
• Last Updated: October 8, 2013

Record last verified: 2013-10

Locations

KR (1)